SEPRAMESH IP BIORESORBABLE BARRIER - PERMANENT MESH

SEPRAMESH IP BIORESORBABLE BARRIER - PERMANENT MESH is an FDA 510(k)-cleared medical device (K040868) manufactured by Genzyme Corp.. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 3, 2004. Regulation: 8.